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Deanxit and Rivotril in Tinnitus Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00841230
First Posted: February 11, 2009
Last Update Posted: August 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Antwerp
  Purpose
The purpose of this study is to investigate whether increased tinnitus reduction can be obtained with Deanxit in patients already receiving Rivotril.

Condition Intervention Phase
Tinnitus Drug: Deanxit Drug: Lactose placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Visual Analogue Scale [ Time Frame: 3 weeks, 6 weeks ]

Estimated Enrollment: 50
Study Start Date: February 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Lactose placebo
1x/day
Drug: Lactose placebo
Lactose used as placebo
Experimental: Deanxit Drug: Deanxit
Deanxit 1x/day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pure tone, narrow band noise or polyphonic tinnitus
  • unilateral or bilateral tinnitus
  • VAS ≥ 4

    • cochleair origin tinnitus
    • tinnitus present 3 months or more
    • age 18y or more
    • intake Rivotril 1mg/d
    • patient 'able to cooperate'
    • patient able to fill in TQ en VAS
    • No pontine angle pathology on MRI

Exclusion Criteria:

  • pulsatile tinnitus
  • pregnancy or breast feeding
  • contra-indications Deanxit
  • recovery myocard infarct
  • conduction disorder His
  • untreated glaucoma
  • MAO inhibitors: 15d stop
  • otosclerosis
  • middle ear pathologies
  • Ménière
  • somatic tinnitus
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841230


Locations
Belgium
Antwerp University Hospital
Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
Principal Investigator: Olivier Meeus, MD University Hospital, Antwerp
  More Information

Responsible Party: Prof Dr P H Van de Heyning, Antwerp University Hospital
ClinicalTrials.gov Identifier: NCT00841230     History of Changes
Other Study ID Numbers: 8/46/260
First Submitted: January 30, 2009
First Posted: February 11, 2009
Last Update Posted: August 11, 2009
Last Verified: August 2009

Keywords provided by University Hospital, Antwerp:
Tinnitus

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Clonazepam
Anticonvulsants
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs